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EMA Product

PreHevbri

Product approved by European Medicines Agency (EU)

Basic Information

PreHevbri

Regulatory Information

EMEA/H/C/005466

Withdrawn

April 25, 2022

February 24, 2022

3

January 30, 2024

Company Information

Netherlands

Queen’s Tower Office Number 714 Delflandlaan 1 1062 EA Amsterdam

Vbi Vaccines Inc.

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations.

Overview Summary

PreHevbri is a vaccine for adults that is used in line with official recommendations to protect against hepatitis B (an infectious disease of the liver caused by hepatitis B virus). By preventing hepatitis B, the vaccine is also expected to protect against hepatitis D (another disease of the liver, caused by the hepatitis D virus). PreHevbri contains three proteins from the outer part of the hepatitis B virus.

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